USA - Pennsylvania - West Point, United States of America
Hybrid
Job Description
Senior Scientist - Localization Analytical Lead
The Global Quality- Large Molecule Analytical Sciences (GQ-LMAS) team leads the global analytical technical oversight of late-stage pipeline programs through commercialization and launch as well as product lifecycle management support for Large Molecules (Vaccines and Biologics), and Cross-Modality Compounds (i.e. Antibody-Drug Conjugates). This team is highly motivated, fast-paced and focused on a robust analytical testing network that enables our company’s strategic priorities to deliver life-changing products through pipeline acceleration and uninterrupted supply of commercial products.
This position plays a critical role in expanding global access to essential biologics and vaccines by enabling high-quality local manufacturing through strong analytical foundations. The Localization Analytical Lead will be responsible for providing strategic and technical leadership for analytical validation, method transfer and lifecycle management to support technology transfer and localization of biologics/vaccines at partner sites. This role will ensure analytical readiness, regulatory compliance, and successful transfer of methods aligned with global standards. This role involves effective communication and teamwork with external partners and cross-divisional collaborations at local site and global levels. This position will also work directly with technical operations, quality, regulatory, analytical program leaders and method subject matter experts on a regular basis
Key Responsibilities:
Define and execute the analytical strategy to support localization, tech transfer, and commercial readiness.
Serve as the primary point of contact for drug substance and drug product testing.
Lead analytical method transfer activities to external partners and ensure receiving sites are prepared with appropriate equipment, training, and systems.
Troubleshoot transfer challenges, implement mitigation strategies and collaborate closely with site teams to ensure successful method adoption and performance.
In partnership with the BCR hub, develop short and long-term strategies for sustainability in BCR inventory and antisera generation needed to support testing at external partner’s laboratories and connect BCR performance with assay performance.
Ensure all analytical activities adhere to cGMP and data integrity standards and partner with QA to address deviations, investigations, and CAPAs related to analytical work.
Support regulatory filings, RTQs for local approvals, PAI readiness and audit observations.
Required Qualifications:
Travel Requirements:
Preferred Experience:
Technical Skills:
Soft Skills:
Key Success Metrics:
Required Skills:
Adaptability, Analytical Method Development, Decision Making, Detail-Oriented, Good Manufacturing Practices (GMP), Quality Standards, Team Problem Solving, Technical TransferPreferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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The salary range for this role is
$106,200.00 - $167,200.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
06/22/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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